DARWIN EU® Drug utilisation of valproate-containing medicinal products in women of childbearing potential

Valproic acid/valproate-containing medicines are first-line treatment for epilepsy, and used as second-line treatments for the treatment of bipolar disorder and migraine prevention. Valproic acid/valproate is a teratogen, with prenatal exposure carrying a substantial risk of neurodevelopmental impairment and congenital malformations in the child. Therefore, its use in women of childbearing age is restricted to prevent valproate exposure during conception and pregnancy.
The European Medicines Agency commissioned this DARWIN EU© study to estimate the incidence rate and prevalence of VPA use and alternative treatments, and to characterise patient-level valproate use in women between aged ≥12 to ≤55 12 and 55 years of age from 2010 to 2022.